Joint Commission Issues Sentinel Alert on Vincristine Administration Errors

In 2005, the Joint Commission issued a Sentinel Alert regarding the prevention of administration errors associated with vincristine.

Several cases of wrong route administration of vincristine had been reported to the U.S. Pharmacopeia (USP) MEDMARX database and to the Joint Commission, some of which culminated in “near miss” events, but one of which resulted in permanent paralysis. Reporting of these errors had historically been erratic, but upon investigation, the Joint Commission noted at least 37 identified cases of similar error since 1968, and mainstream media began reporting cases as well (Joint Commission, 2005). Because the errors result in such tragic outcomes (slow, progressive, painful paralysis, usually resulting in death), the Joint Commission made the unusual decision to announce an alert to identify strategies for minimizing these errors and providing administration recommendations.

The Joint Commission identified several areas of concern in the labeling, handling, and administration of vincristine, including the following.

  • Labeling: USP standards required that vincristine syringes should be labeled stating “FATAL IF GIVEN INTRATHECALLY. FOR IV USE ONLY. DO NOT REMOVE COVERING UNTIL MOMENT OF INJECTION.” Each syringe should also have an additional wrapping with the same warning printed on it. The Joint Commission identified that some practitioners may not be aware of the labeling requirements.
  • Early removal of overwrap: Error risks increased when healthcare practitioners removed the overwrap before the actual injection, allowing for inadvertent intrathecal administration.

Failure to check physician orders carefully and unfamiliarity with vincristine and its properties were also identified as sources of error.

To address these concerns, practitioners at the Dana-Farber Cancer Institute in Boston, MA, developed a safety program that included many safeguards to ensure accurate administration of vincristine, such as

  • Specific syringe and overwrap labeling
  • Following special preparation protocols: Drug is prepared only at time of administration, and is dispensed only to the person who will administer it.
  • Attaching a unique filter to the syringe
  • Requiring administration to occur in a room separate from where other medications are administered.

Another proposed method for decreasing risk was to prepare and administer vincristine in minibags only, which, although requiring additional preparation time, eliminates the risk of inadvertent intrathecal administration entirely.

Subsequently, the Joint Commission took the unusual step to issue a number of recommendations for administration of vincristine. Its recommendations include dilution of vincristine in a volume (preferably in a minibag) that will avoid potential accidental intrathecal administration; clear and specific USP labeling of the syringe and the outerwrap of any vincristine to be delivered via syringe; refraining from administration of vincristine to a location where any intrathecal medication may be being administered; and assurance that at least two qualified healthcare professionals independently verify and document the drug, dose, and route at the time of preparation and administration (Joint Commission, 2005).

After the Joint Commission alert, the World Health Organization (WHO, 2007) published a similar report supporting the Joint Commission recommendations and including a recommendation to develop separate and unique delivery systems for IV and spinal drug delivery. WHO recommended a unique “lock and key” system that would make it physically impossible to attach an IV syringe containing vincristine to a spinal needle.

View the full Joint Commission alert.

View a video from WHO.

View a video from the U.S. Food and Drug Administration.

Category 
References 

Joint Commission. (2005, July 14). Sentinel event alert, issue 34: Preventing vincristine administration errors. Retrieved from http://www.jointcommission.org/sentinel_event_alert_issue_34_preventing_vincristine_administration_errors

World Health Organization. (2007). Patient safety: Vincristine sulphate. Retrieved from http://www.who.int/patientsafety/activities/technical/vincristine/en/index.html

 


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